Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-02-23 @ 8:09 PM
Study NCT ID:
NCT04125394
Status:
UNKNOWN
Last Update Posted:
2020-10-08
First Post:
2019-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Tolerance of Hypertonic Sodium Chloride (NaCl 5%) Eye Drops Without Preservatives in Corneal Edema
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015715', 'term': 'Corneal Edema'}], 'ancestors': [{'id': 'D003316', 'term': 'Corneal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-02-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-05', 'studyFirstSubmitDate': '2019-10-11', 'studyFirstSubmitQcDate': '2019-10-11', 'lastUpdatePostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants with Treatment-Related Adverse Events (Objective Tolerance)', 'timeFrame': 'Baseline, Day 7 and Day 28', 'description': 'Slit Lamp Examination'}, {'measure': 'Score in Subjective Tolerance Test', 'timeFrame': 'Day 7 and Day 28'}], 'primaryOutcomes': [{'measure': 'Mean Change from Baseline in Visual acuity', 'timeFrame': 'Baseline, Day 7 and Day 28'}], 'secondaryOutcomes': [{'measure': 'Mean Change from Baseline in Corneal Thickness', 'timeFrame': 'Baseline, Day 7 and Day 28', 'description': 'Micrometers'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['corneal edema', 'sodium chloride', 'single-dose'], 'conditions': ['Corneal Edema']}, 'descriptionModule': {'briefSummary': 'Corneal edema is frequently found in clinical practice as a common sign of acute corneal disease due to different etiologies that cause an accumulation of extracellular fluid in the cornea. The present unicentric clinical trial aims to evaluate the efficacy and tolerance of an ophthalmic solution of hypertonic sodium chloride (NaCl 5%) without preservatives in participants suffering from symptomatic corneal edema.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age over 18 years\n* Clinical diagnosis of symptomatic corneal edema related to chronic epithelial, secondary to corneal dystrophies, controlled infectious and inflammatory pathologies and surgical trauma already resolved.\n* No need for keratoplasty in the 6 months following the start of the study\n\nExclusion Criteria:.\n\n* Visual acuity less than 1/20 in both eyes\n* Corneal edema caused by the following acute etiologies: trauma, infection, inflammation or Stevens-Johnson syndrome.\n* Glaucoma or uncontrolled hypertension.\n* Known allergy to any of the ingredients of the product.'}, 'identificationModule': {'nctId': 'NCT04125394', 'briefTitle': 'Efficacy and Tolerance of Hypertonic Sodium Chloride (NaCl 5%) Eye Drops Without Preservatives in Corneal Edema', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tiedra Farmacéutica SL'}, 'officialTitle': 'Unicentric Clinical Trial on the Clinical Efficacy and Tolerance of the Treatment With an Ophthalmic Solution of Hypertonic Sodium Chloride (NaCl 5%) Without Preservatives in Patients Suffering From Symptomatic Corneal Edema', 'orgStudyIdInfo': {'id': 'TCL/CSH/022019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NaCl 5%', 'description': 'Hypertonic sodium chloride (NaCl 5%) eye drops solution in single-dose, without preservatives, administered every 8 hours for 28 days.', 'interventionNames': ['Device: hypertonic Sodium chloride (NaCl 5%) eye drops solution in single-dose']}], 'interventions': [{'name': 'hypertonic Sodium chloride (NaCl 5%) eye drops solution in single-dose', 'type': 'DEVICE', 'otherNames': ['Ocumax 5 eye drops solution in single-dose'], 'description': 'Ophthalmic solution of hypertonic sodium chloride (NaCl 5%) without preservatives in single-dose container', 'armGroupLabels': ['NaCl 5%']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alcalá de Henares', 'country': 'Spain', 'contacts': [{'name': 'Rafael Cañones', 'role': 'CONTACT'}], 'facility': 'Hospital Universitario Príncipe de Asturias', 'geoPoint': {'lat': 40.48205, 'lon': -3.35996}}], 'centralContacts': [{'name': 'Tiedra Farmaceutica', 'role': 'CONTACT', 'email': 'info@tiedra.net', 'phone': '+34 91 643 41 40'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tiedra Farmacéutica SL', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Hospital Universitario Principe de Asturias', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}